AEDMAX.PL - we are the sole distributor of Philips AED devices in Poland, and our facilities include an experienced team of rescuers, firefighters, instructors and technology specialists, as well as first aid enthusiasts. We are a team that creates modern security systems - both in workplaces, means of transport and public places. So far, we have installed over 5,000 AED defibrillators, thus setting new standards. We design and implement early access defibrillation programs (PAD – Public Access Defibrillation). We cooperate with organizations and local governments throughout the country. We equip institutions, places and public transport with reliable equipment and maximize both awareness of the importance of early defibrillation and access to more AEDs. We expand and build knowledge about first aid because we believe that together we can create a responsible society that is properly prepared to save human lives. In these activities, we are constantly supported by a professional team of several dozen instructors throughout the country, who have already trained over 30,000 people.
We are the undisputed leader in the sale of defibrillators on the Polish market. Our main goal is to increase social awareness in the field of security and to meet the needs and expectations of customers. We are constantly working on improving the quality of our services and strengthening our market position in our specialty.
We operate in the Integrated Management System compliant with the PN-EN ISO 9001:2015 and PN-EN ISO 13485:2016 standards, successfully implemented in 2021, covering the system of quality and safety of medical devices. The whole thing has been fully documented and is used in order handling, storage and sale of AED devices. The need to implement the Integrated Management System described above was dictated by the EU regulation of April 5, 2017 - Medical Device Regulation. The new MDR introduces various changes to the regulations for medical devices on the EU market, which will be successively enforced until 2025. However, most of them apply from 25 May 2021.
Pursuant to Art. 14 of Regulation 2017/745, it is the distributor's duty to verify that:
- the product has the CE mark and whether a Declaration of Conformity is available
- the label and instructions for use contain information in the language required by the country
- the details of the importer are given on the product or in the accompanying document
- the manufacturer has assigned a UDI code to the device
Distributors and importers are also responsible for the compliance and safety of the products and are therefore required to:
- suspend the making available of products that may not be compliant with the MDR and inform the manufacturer and the authorized representative and the importer about it
- inform the national supervisory authority about a product that may be counterfeit or poses a serious risk
- cooperate with the manufacturer, his authorized representative, importer and competent authorities in order to ensure compliance of the product or withdrawal from the market or use
Like importers, AEDMAX.PL Sp. z o. o. being the sole distributor of Philips AED devices, it is obliged to:
- ensure storage or transport conditions in accordance with the manufacturer's instructions
- keeping a register of complaints about non-conforming products and cases of withdrawing from use and withdrawal from the market, as well as informing the
- manufacturer and authorized representative and the importer
- providing information about complaints and suspected incidents from healthcare professionals, patients or users, to the manufacturer and authorized representative and importer
By improving the Integrated Management System in accordance with the standards PN-EN ISO 9001:2015, PN-EN ISO 13485:2016 and the legal requirements in the field of supervising orders and sales of medical devices, we achieve our goals. By strategically managing our company, we want to coordinate actions taken in the field of safety of medical products from the point of view of our clients, which ensures long-term development of the company. We constantly define and update the quality and safety policy, which is implemented through:
- development of cooperation with suppliers, which is a guarantee of high quality supplies
- reliable customer service and continuous improvement of activities in this area
- maintaining product quality and safety
- guarantee of proper order handling, storage, sales and replacement of consumable accessories in accordance with the specifications of the manufacturer of medical devices
- performing all activities in a way that minimizes the emergence of threats to the safety of the medical device
- care for the natural environment
- planned and systematic improvement of professional competences of the company's employees
- development of a pro-quality attitude and a sense of responsibility of employees for the safety of supplied medical devices
- compliance with the principles of sustainable development
We always act ethically, applying the principle of continuous improvement of standards of cooperation, durability and quality as well as safety of medical devices. At the same time, we are working on a training system for users of devices offered by our company.
The AEDMAX.PL company always professionally and conscientiously fulfills the obligations arising from the contracts binding it with contractors, often engaging in tasks that go beyond their scope. It is also worth emphasizing the fact of efficient and timely delivery of equipment and support in the implementation of projects at every stage of their duration. We build relationships with our business partners based on mutual trust. A great advantage of AEDMAX.PL is efficient and comprehensive service for individual customers and online orders. We are constantly working on expanding our portfolio to meet the requirements and needs of our partners. We are happy to share knowledge and ideas that allow you to successfully implement business assumptions. We provide professional substantive support of our team and we guarantee full availability of products, as well as efficient execution of orders.
High qualifications of people building AEDMAX.PL, focus on customer needs, excellent organization and full commitment are the company's flagship.